NCT05814419

Brief Summary

If a child from the Healthy Hearts and Minds education and screening program is found to have a genetic marker for familial hyperlipidemia (FH), immediate family members are offered genetic testing at no charge to identify those at high risk for cardiovascular disorders and those who carry the genetic markers. If identified early, the risk for cardiovascular disease can be greatly modified by early and proper treatment. The aim of the study is to gauge the impact of large-scale surveillance testing to identify those with the disorder and improve clinical care. This impact is both in disease prevention and in lessening the cost of long-term care from premature cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 19, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

March 2, 2023

Results QC Date

July 30, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

CholesterolSchool basedBiometric ScreeningGeneticHealthy HeartsChildren

Outcome Measures

Primary Outcomes (1)

  • Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant

    Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.

    The duration of participation in study is one day.

Eligibility Criteria

Age6 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

As above

You may qualify if:

  • \* Primary family member of child from school screening program with documented familial hyperlipidemia (FH) variant

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80528, United States

Location

Results Point of Contact

Title
Gary J Luckasen, MD
Organization
UCHealth

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2023

First Posted

April 14, 2023

Study Start

February 17, 2023

Primary Completion

May 29, 2025

Study Completion

May 29, 2025

Last Updated

December 19, 2025

Results First Posted

December 19, 2025

Record last verified: 2025-12

Locations